Z-1521-2009

Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size...

Name: Z-1521-2009 Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size...
Creator: Zimmer Inc.
Published: 2009-04-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-04-17 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size D Left, sterile, Zimmer, Warsaw, IN; REF... on 2009-04-17. The reason FDA records is "The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1521-2009
Status: Terminated
Initiated: 2009-04-17
Posted: 2009-06-25
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
Product: Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size D Left, sterile, Zimmer, Warsaw, IN; REF 00-5964-014-51.
Product code: NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Consignees were notified by phone beginning on 4/17/09 and email and letter notifications were sent on 4/22/09. A dear surgeon letter entitled Urgent: Medical Device Recall, dated April 28, 2009, is being sent to implanting surgeons recommending patient monitoring. Consignees are to return the response form indicating their receipt of the notification. Questions or concerns should be directed to (800) 846-4637 or www.zimmer.com.
Quantity in commerce: 1
Distribution: Worldwide Distribution -- USA including states of Arizona, California, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, Ohio, Oregon, and Pennsylvania and country of Canada.
Product codes and lots: Lot 61219714.

Product code NJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)